510(k) · Cleared
ClearedCure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cure Medical, LLC · EZD Catheter, Straight
Cleared on Dec 23, 2013 as substantially equivalent to K072539 (Cure Medical, LLC, 2007) and 1 other predicate after a 136-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 23, 2013
- Review
- 136 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896729 (1990). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 3 generations backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- 2 generations backK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
- 1 generation backK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
- This deviceK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
- Descendant · cites it directly · 0 of its ownK260737 Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female…Convatec · 2026
- Descendant · cites it directly · 0 of its ownK181445 AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151745 FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec · 2026 · cites it directly0descendants
- K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018 · cites it directly0descendants
- K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −3 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| −2 | K072539 | Cure Catheter | Cure Medical, LLC | 2007 | 1 |
| −1 | K110653 | Cure Catheter | Cure Medical, LLC | 2011 | 1 |
| 0 (this device) | K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter… | Cure Medical, LLC | 2013 | — |
| +1 | K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 -… | Convatec | 2026 | — |
| +1 | K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018 | — |
| +1 | K151745 | FULL CARE Disposable PVC Nelaton Catheter | Shaoxing Fuqing Health Products Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072539 | Cure CatheterSummary page 2…Use Urinary Catheter 510(k) IK072539 K110653 K050874 K(023254 Device Features Hydrophilic coated,… | 2007 |
| * | K110653 | Cure CatheterSummary page 1…876.5130 Cure Medical Cure Catheter I K(072539 Predicate Device(s): Cure Pediatric Catheter j K110653 Astra Tech AB LoFric® PrimatM Single Use Urinary Catheter I Reference Devices(s):… | 2011 |
| † | K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | 2005 |
| † | K023254 | Speedicath | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K260737 (Convatec, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072539.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The Cure Catheter® Hydrophilic Coated Is an Intermittent urinary catheter that Is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes In a variety of sizes, packaged sterile for single-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132500
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026